Sr Engineer (Medical Device Reliability)

Fresenius Kabi USA • Warrendale, PA

1d • $85,000 - $95,000 • Hybrid

About The Position

The Senior Engineer, Reliability can play a key contributor role in our Hardware Development Team and reliability programs. This role plans and contributes to the reliability program activities to meet the reliability, safety, quality, and business goals. The Senior Engineer, Reliability, work under moderate supervision. Participates in designing, building and maintaining of processes and documentation to test, report and improve the reliability of medical device hardware and software.

Requirements

• BS degree in Engineering, or commensurate experience
• Minimum 3 year(s) of hands-on experience as a reliability engineer on product development teams
• Experience with electromechanical assemblies and complex mechanisms
• Proven capability in data analysis, reliability testing, and test design.
• Ability to create engineering documents including Test Plans, Protocols, and Reports.
• Experience using PLM to manage database and documentation revisions in accordance with FDA requirements
• Ability to work as a collaborative team member.
• Analysis, troubleshooting, and debugging skills. Experience with SQL is a plus.
• Experience with developing and running reliability test protocols
• Task management skills with ability to prioritize multiple assignments with minimal supervision.
• Experience in data capture and manipulation in software tools such as Excel and Access. Proficiency in analyzing data to support reliability metrics
• Ability to diagnose and solve problems involving multiple technologies (i.e. mechanical, electrical, software).
• Follow OSHA 29CFR 1910.1030 regulations
• Natural inclination to be methodical and hands-on in a development lab environment.
• Attention to details, natural inclination to be methodical and hands-on in a development lab environment.
• Strong problem solving and analytical skills.
• The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Nice To Haves

• Experience with SQL is a plus.

Responsibilities

• Plans, designs, executes, documents, and analyzes a regimen of tests to predict the reliability of new products and product changes.
• Operates within defined processes and procedures consistent with a regulated environment. Works on problems of simple to moderate scope where analysis of situations or data requires a review of a variety of factors.
• Effectively operates as an individual contributor and a member of the large team. Exercises judgment within defined procedures and practices to determine appropriate action.
• Participates in technical reviews and responsible for organizing data and preparing appropriate documentation for assigned projects.
• Maintains reliability test equipment including the execution of regular maintenance activities.
• Accurate recording of test results and defects in Excel, Jira, or other test databases.
• Assists in root cause analysis of Field Returns and Reliability Test failures.
• Develops and maintains detailed troubleshooting documentation, for both internal and external customers. Assists in documentation, tracking, and analysis of field failure data.
• Develops and executes written test protocols designed to evaluate and demonstrate product reliability including but not limited to QALT (Quantitative Accelerated Life Testing) and Reliability Life Testing.
• Develops, fabricates, and qualifies reliability test fixtures.
• Design in collaboration to the Hardware and Sustaining teams and develop processes, tools or fixtures for testing products.
• Organizes test records to ensure that records are indexed, archived, and can be retrieved.
• Evaluates results relative to program goals. Applies standard techniques to solving difficult problems.
• Applies functional understanding of reliability theories and practices to daily activities.
• Display full understanding and knowledge of regulations to apply guidance and standards on reliability activities and work products; prepare documentation for compliance with standard operating procedures.
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Benefits

• 401(k) plan with company contributions
• paid vacation
• holiday and personal days
• employee assistance program
• health benefits to include medical, prescription drug, dental and vision coverage
• life insurance
• disability
• wellness program

What This Job Offers

• Job Type: Full-time
• Career Level: Senior